A new package and delivery method have been issued for Micotil® 300 (tilimicosin injection), a popular cattle and sheep antibiotic with a long history of human safety concerns.
The U.S. Food and Drug Administration (FDA) recently approved a new label for Micotil 300, with details the modifications in packaging and delivery of the drug. Elanco Animal Health, sponsor of Micotil 300, worked with the FDA to reduce the risk to human handlers using the product to treat animals.
According to communication published by the FDA, human injection with Micotil can lead to “severe cardiac effects and death.” The agency issued a safety alert in 2017 underscoring the human health risks associated with accidental Micotil injection or exposure.
The new packaging is intended to decrease the risk of human exposure to the drug via accidental injection as well as other possible routes, including through the mouth, on the skin, or in the eye.
A new protective, tamper-proof shroud fully encases the product and prevents direct access to the vial. The medication only can be drawn out using a quick-fit connector developed to specifically fit the shroud. The connector also is equipped with a tube-fed safety syringe; both pieces are available only from Elanco or its distributors.
The label also cautions not to use Micotil 300 with automatically powered syringes, single-use syringes, or any other delivery devices. Specific instructions for changing and disposing of needles also are new to the label.
The FDA emphasized that every person who handles Mictotil 300 be fully trained on using the drug safely. Safe use and handling instructions are attached to the shroud so users can review the information each time they use the product.
The agency also underscored the importance of using Micotil 300 only in a controlled setting with proper cattle restraint.
